FDA Inspection
Jubilant Cadista Pharmaceuticals, Inc.Jubilant Cadista Pharmaceuticals, Inc. – FDA Inspection, Aug 7, 2015
Record Details
This FDA Inspection record concerns Jubilant Cadista Pharmaceuticals, Inc., with an inspection on August 7, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 7, 2015
- Product Type
- Drugs
View Company Profile
ID · 61646c48-445a-4b8e-a7b7-6b8d0e753a5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940733
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jubilant Cadista Pharmaceuticals, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2020 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 8, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 1, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Jubilant Cadista Pharmaceuticals, Inc.
- FDA Inspection 1120136 - 2020-02-28
- FDA Inspection 888209 - 2014-07-08
- FDA Inspection 842669 - 2013-08-01
- FDA Inspection 774268 - 2012-04-05
- FDA Inspection 715587 - 2011-03-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.